Back to resultsEffects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients
Primary Purpose
Intestinal Bacteria Flora Disturbance, Constipation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Bacteria Flora Disturbance focused on measuring probiotic, metagenomic, constipation
Eligibility Criteria
Inclusion Criteria:
- Agree to adhere to the procedures and requirements of the study and attend the institute on the day (s) and time (s) determined for the evaluations;
- Being able to consent study participation
Have one or more complaints of change in bowel habits in the last 3 months with onset of symptoms at least 6 months before diagnosis, as described below:
- Evacuation effort for at least 25% of defecations
- Lumpy stools, on sausage-shaped or hardened in at least 25% of stools, according to the Bristol scale. number 1, 2 or 3;
- Incomplete evacuation count in at least 25% of defecations;
- Feeling of anorectal obstruction / blockage of feces in at least 25% of defecations;
- Manufactured manuals to facilitate at least 25% of stools (for example, evacuation with digital help, pelvic floor support)
Exclusion Criteria:
- Pregnancy or breast-feeding;
- Known intolerance or allergy to any of the study products;
- Previous history of gastrointestinal surgery;
- Patients with celiac disease or inflammatory bowel disease;
- Patients with psychiatric, cardiologic, respiratory, renal and hepatic disease;
- No acceptance of study admission by the participant; Diagnosis of Clostridium difficile diarrhea in the last 3 months;
- Patients with known immunosuppressive disease;
- Any other gastrointestinal pathology;
- Prior use of antibiotics in less than 30 days;
- Frequent use of laxatives or other medication that alters bowel motility (one week without Use before inclusion)
- Regular treatment with probiotics / symbiotic, including regular use of yogurt with probiotics (One week before use before inclusion)
- Regular use of antidepressant, opioid analgesic, antispasmodic or anticholinergic agents
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
probiotic
Placebo
Arm Description
Probiotic consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019 (Probiatop), Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.
Placebo consists of maltodextrin. Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.
Outcomes
Primary Outcome Measures
Increased number of bowel movements
Participants will record the number of defecations per day in a daily diary during the study
Secondary Outcome Measures
Incidence of Adverse events
Participants will record the adverse events in a daily diary during study
Changes of intestinal bacteria flora
Quantitative analysis of the participants' microbiota bacteria by sequencing the 16S rDNA gene and the readings obtained from each participant werw compared with genomic banks for identification of the microorganism.
Improve the quality of life of participants evaluated through quality of life questionnaire
The evaluation was performed through quality of life questionnaire.
Evaluation of symptoms of constipation
Improvement of symptoms of constipation by criteria and Bristol scale
Improvement of symptoms of constipation
Improvement of symptoms of constipation by ROME III
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03103958
Brief Title
Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients
Official Title
Phase IV, Double Blind, Randomized, Study Between Probiatop and Placebo for the Assessment of Improving the Gastrointestinal Function and Intestinal Bacterial Flora in Constipated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 28, 2016 (Actual)
Primary Completion Date
August 9, 2016 (Actual)
Study Completion Date
September 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Farmoquimica S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will be correlated with the Quality of Life Questionnaire answers obtained from participants with intestinal transit problem. The Increase in the number of evacuations, as well as the improvement of complaints related to intestinal transit alteration will be evaluated during the study. The participants will use probiotic or placebo for a period of 28 days and the gastrointestinal function questionnaire and collect stool will be performed before the study and after period of treatment
Detailed Description
It is a double-blind, randomized, placebo control study that evaluated the action of a probiotic in relation to a placebo in the human intestinal microbiome by the technique of metagenomics, as well as evaluated the effects of this probiotic on the gastrointestinal transit of constipated participants.
One hundred and twenty constipated patients will be randomized into two groups:Probiatop or Placebo. The first 22 patients from each group will also perform a metagenomic evaluation through the stool sample collection before and after of treatment. Besides these procedures, all patients will fill out a symptom assessment questionnaire at baseline of the study, and then after 14 and 28 days after the beginning of the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Bacteria Flora Disturbance, Constipation
Keywords
probiotic, metagenomic, constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic
Arm Type
Active Comparator
Arm Description
Probiotic consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019 (Probiatop), Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo consists of maltodextrin. Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Probiatop
Intervention Description
Probiatop is a live microbial preparation saches containing 1g of the formulation composed by Lactobacillus acidophilus NCFM, 10⁹, Lactobacillus rhamnosus HN001 10⁹, Lactobacillus paracasei LPC-37 10⁹, Bifidobacterium lactis HN019 10⁹ combined with Polydextrose.
Subjects will take two sachets per day after diluting them in 100 ml of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo sachets were prepared by substituting equivalent amounts of Maltodextrin for the probiotic powder.
Subjects will take two sachets per day after diluting them in 100 ml of water
Primary Outcome Measure Information:
Title
Increased number of bowel movements
Description
Participants will record the number of defecations per day in a daily diary during the study
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of Adverse events
Description
Participants will record the adverse events in a daily diary during study
Time Frame
28 days
Title
Changes of intestinal bacteria flora
Description
Quantitative analysis of the participants' microbiota bacteria by sequencing the 16S rDNA gene and the readings obtained from each participant werw compared with genomic banks for identification of the microorganism.
Time Frame
28 days
Title
Improve the quality of life of participants evaluated through quality of life questionnaire
Description
The evaluation was performed through quality of life questionnaire.
Time Frame
28 days
Title
Evaluation of symptoms of constipation
Description
Improvement of symptoms of constipation by criteria and Bristol scale
Time Frame
28 days
Title
Improvement of symptoms of constipation
Description
Improvement of symptoms of constipation by ROME III
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Agree to adhere to the procedures and requirements of the study and attend the institute on the day (s) and time (s) determined for the evaluations;
Being able to consent study participation
Have one or more complaints of change in bowel habits in the last 3 months with onset of symptoms at least 6 months before diagnosis, as described below:
Evacuation effort for at least 25% of defecations
Lumpy stools, on sausage-shaped or hardened in at least 25% of stools, according to the Bristol scale. number 1, 2 or 3;
Incomplete evacuation count in at least 25% of defecations;
Feeling of anorectal obstruction / blockage of feces in at least 25% of defecations;
Manufactured manuals to facilitate at least 25% of stools (for example, evacuation with digital help, pelvic floor support)
Exclusion Criteria:
Pregnancy or breast-feeding;
Known intolerance or allergy to any of the study products;
Previous history of gastrointestinal surgery;
Patients with celiac disease or inflammatory bowel disease;
Patients with psychiatric, cardiologic, respiratory, renal and hepatic disease;
No acceptance of study admission by the participant; Diagnosis of Clostridium difficile diarrhea in the last 3 months;
Patients with known immunosuppressive disease;
Any other gastrointestinal pathology;
Prior use of antibiotics in less than 30 days;
Frequent use of laxatives or other medication that alters bowel motility (one week without Use before inclusion)
Regular treatment with probiotics / symbiotic, including regular use of yogurt with probiotics (One week before use before inclusion)
Regular use of antidepressant, opioid analgesic, antispasmodic or anticholinergic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludmila Donato, Monitor
Organizational Affiliation
FQM
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients
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